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This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test lens C | Experimental | Test lens C from previous study |
|
| Test lens A | Active Comparator | Test lens A from previous study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Day Acuvue Moist | Device | Lenses will be worn in a daily wear modality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial Length of the Eye | Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis. | Baseline and every 6 months post-baseline up to 18 months |
| Spherical Equivalent Refractive Error | Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. | Baseline and every 6 months up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36809645 | Derived | Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens C | Test lens C from previous study |
| FG001 | Test Lens A | Test lens A from previous study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline summary was conducted on all randomized subjects in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Lens C | Test lens C from previous study |
| BG001 | Test Lens A | Test lens A from previous study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Axial Length of the Eye | Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis. | All subjects who have at least one data point. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline and every 6 months post-baseline up to 18 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Lens C | Test lens C from previous study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| XU CHENG, PRINCIPAL CLINICAL SCIENTIST | Vistakon USA | 1 904 443-1245 | xcheng6@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lost to Follow-up |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Spherical Equivalent Refractive Error | Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. | All subjects who have at least one data point. | Posted | Mean | Standard Deviation | diopter (D) | Baseline and every 6 months up to 18 months |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Test Lens A | Test lens A from previous study | 0 | 42 | 0 | 42 |
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| Change from baseline at 18 months |
|